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Randomized Controlled Trial
Randomized clinical trial of chemoembolization plus radiofrequency ablation versus partial hepatectomy for hepatocellular carcinoma within the Milan criteria.
- H Liu, Z-G Wang, S-Y Fu, A-J Li, Z-Y Pan, W-P Zhou, W-Y Lau, and M-C Wu.
- Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.
- Br J Surg. 2016 Mar 1; 103 (4): 348-56.
BackgroundThis study aimed to compare sequential treatment by transcatheter arterial chemoembolization (TACE) and percutaneous radiofrequency ablation (RFA) with partial hepatectomy for hepatocellular carcinoma (HCC) within the Milan criteria.MethodsIn a randomized clinical trial, patients with HCC within the Milan criteria were included and randomized 1 : 1 to the partial hepatectomy group or the TACE + RFA group. The primary outcome was overall survival and the secondary outcome was recurrence-free survival.ResultsTwo hundred patients were enrolled. The 1-, 3- and 5-year overall survival rates were 97·0, 83·7 and 61·9 per cent for the partial hepatectomy group, and 96·0, 67·2 and 45·7 per cent for the TACE + RFA group (P = 0·007). The 1-, 3- and 5-year recurrence-free survival rates were 94·0, 68·2 and 48·4 per cent, and 83·0, 44·9 and 35·5 per cent respectively (P = 0·026). On Cox proportional hazard regression analysis, HBV-DNA (hazard ratio (HR) 1·76; P = 0·006), platelet count (HR 1·00; P = 0·017) and tumour size (HR 1·90; P < 0·001) were independent prognostic factors for recurrence-free survival, and HBV-DNA (HR 1·61; P = 0·036) was a risk factor for overall survival. The incidence of complications in the partial hepatectomy group was higher than in the TACE + RFA group (23·0 versus 11·0 per cent respectively; P = 0·024).ConclusionFor patients with HCC within the Milan criteria, partial hepatectomy was associated with better overall and recurrence-free survival than sequential treatment with TACE and RFA.Registration NumberACTRN12611000770965 (http://www.anzctr.org.au/).© 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.
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